Label: THROAT RELIEF POPS- pectin lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 10, 2022

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  • ACTIVE INGREDIENT

    Active ingredient (in each pop)

    Pectin 10 mg

  • PURPOSE

    Purpose

    Oral demulcent

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

  • WARNINGS

    Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

  • STOP USE

    Stop use and ask doctor if

    • irritation, pain or redness persists or worsens

    • sore mouth does not improve in 7 days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 3 years and over - allow 1 pop to dissolve slowly in mouth. May be repeated as necessary or as directed by a doctor.

    children under 3 years - ask a doctor

  • OTHER SAFETY INFORMATION

    Other information:

    • 15 calories per pop

    • not a candy

  • INACTIVE INGREDIENT

    Inactive ingredients: Ascorbic acid, citric acid, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, sodium ascorbate, soybean oil, sucrose, water and zinc gluconate.

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

  • PRINCIPAL DISPLAY PANEL

    HEB Pectin Throat Pop 20ct

  • INGREDIENTS AND APPEARANCE
    THROAT RELIEF POPS 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (Red and Purple) Scoreno score
    ShapeROUNDSize20mm
    FlavorCHERRY (cherry and grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-134-2020 in 1 BAG; Type 0: Not a Combination Product07/31/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2018
    Labeler - HEB (007924756)
    Registrant - Bestco Inc (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(37808-134)
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